- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00082940
Denileukin Diftitox in Treating Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia
A Phase II Study of ONTAK® (Denileukin Diftitox, DABIL-2) in Patients With Fludarabine-Refractory B-Cell Chronic Lymphocytic Leukemia
RATIONALE: Biological therapies, such as denileukin diftitox, may interfere with the growth of cancer cells and slow the growth of chronic lymphocytic leukemia.
PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating patients with fludarabine-refractory B-cell chronic lymphocytic leukemia.
Study Overview
Detailed Description
OBJECTIVES:
Primary
- Determine the complete and partial response rate in patients with fludarabine-refractory B-cell chronic lymphocytic leukemia treated with denileukin diftitox.
Secondary
- Determine the toxicity profile of this drug in these patients.
- Determine the response rate in patients (regardless of CD25 receptor density) treated with this drug.
- Determine the progression-free survival and overall survival of patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive denileukin diftitox IV over 1 hour on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Patients achieving a complete response after 8 courses proceed to follow-up. Patients achieving a partial response or stable disease after 8 courses may continue treatment at the discretion of the investigator.
Patients are followed every 3 months for 1 year and then annually until relapse.
PROJECTED ACCRUAL: A total of 12-44 patients will be accrued for this study within 1 year.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Orange, California, United States, 92868-3849
- St. Joseph Hospital Regional Cancer Center - Orange
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Illinois
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Chicago, Illinois, United States, 60611
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University
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Indiana
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Vincennes, Indiana, United States, 47591
- Medical Center Vincennes
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Louisiana
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Houma, Louisiana, United States, 70360
- Cancer Care Specialists
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Shreveport, Louisiana, United States, 71130-3932
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences
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Michigan
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Detroit, Michigan, United States, 48202
- Josephine Ford Cancer Center at Henry Ford Health System
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North Carolina
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Goldsboro, North Carolina, United States, 27534
- Southeastern Medical Oncology Center
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Winston-Salem, North Carolina, United States, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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South Carolina
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Spartanburg, South Carolina, United States, 29303
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
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Tennessee
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Chattanooga, Tennessee, United States, 37404
- Chattanooga Oncology and Hematology Associates
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Texas
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Austin, Texas, United States, 78705
- Southwest Regional Cancer Center - Central
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Diagnosis of B-cell chronic lymphocytic leukemia (CLL) meeting the following criteria at any time during the course of disease (e.g., at initial diagnosis or relapse):
- Absolute lymphocytosis > 5,000/mm^3
- Lymphocytes must appear mature with < 55% prolymphocytes
- More than 30% of all nucleated cells are lymphoid on bone marrow aspirate smear
- Lymphoid infiltrates compatible with bone marrow involvement by CLL on core bone marrow biopsy
- Predominant B-cell monoclonal population of cells share the B-cell marker (CD19) with the CD5 antigen in the absence of other pan-T-cell markers by lymphocyte immunophenotyping
High-risk disease OR intermediate-risk disease
Patients in the intermediate-risk group must have evidence of active disease as demonstrated by at least 1 of the following criteria:
- Massive or progressive splenomegaly and/or adenopathy
- Weight loss > 10% within the past 6 months
- Common toxicity grade 2-4 fatigue
- Fevers > 100.5°F OR night sweats for more than 2 weeks without evidence of infection
- Progressive lymphocytosis with an increase of > 50% over a 2-month period or an anticipated doubling time of < 6 months
Failed at least 1 prior fludarabine regimen, as defined by 1 of the following criteria:
- Refractory or intolerant to fludarabine
- Relapsed within 6 months after completion of fludarabine
- No CNS leukemia
- No mantle cell lymphoma in leukemic phase
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-2
Life expectancy
- More than 2 months
Hematopoietic
- Absolute neutrophil count ≥ 1,000/mm^3
- Platelet count ≥ 50,000/mm^3
- Hemoglobin ≥ 8 g/dL (transfusion allowed)
Hepatic
- Albumin ≥ 3 g/dL
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- No hepatitis B or C infection
Renal
- Creatinine ≤ 1.5 mg/dL OR
- Creatinine clearance ≥ 40 mL/min
Cardiovascular
- LVEF ≥ 40%
Other
- No uncontrolled infection
- No other concurrent serious illness
- No HIV infection
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use two effective methods of contraception (one must be non-hormonal) during and for at least 1 month after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Prior denileukin diftitox allowed
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- No concurrent corticosteroids as anti-emetics
Radiotherapy
- No concurrent radiotherapy
Surgery
- Not specified
Other
- At least 28 days since prior anticancer therapy and recovered
- No other concurrent antineoplastic drugs
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Arthur E. Frankel, MD, Wake Forest University Health Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCCWFU-27102
- CDR0000361734 (Registry Identifier: PDQ (Physician Data Query))
- CCCWFU-BG02-331
- LIGAND-CCCWFU-27102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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